Structurally encoded implantable devices

ABSTRACT

An implant device identifiable after implantation comprises a main portion of the implant device and a coded portion of the implant device. The coded portion comprises a radiopaque element and indicia on the radiopaque element or indicia as a plurality of radiopaque elements disposed within the coded portion. The indicia are discernible by x-ray, fluoroscopy, computed tomography, electromagnetic radiation, ultrasound, or magnetic resonance imaging.

FIELD OF THE INVENTION

The present invention relates to identifiable implants and, inparticular, structurally encoded implant devices.

BACKGROUND OF THE INVENTION

Medical implant devices used in surgical procedures can be associatedwith particular information to guide medical professionals before andafter the surgical procedure. Each implant device carries a wealth ofinformation that is valuable to the patient, the implant manufacturer,medical researchers, healthcare professionals, and medical facilities.However, the information, which may include the implant manufacturer andmanufacturer's lot number, the date and location of surgicalimplantation, the responsible surgeon, any medical notes, photographs,or diagrams relating to the implant, surgery, or condition, may not beadequate, properly recorded, or readily accessible for beneficial use bya healthcare professional, implant manufacturer, or medical researcherafter implantation. Problems relating to poor implant records can leadto unnecessary delay or even medical error by healthcare professionals.Moreover, there are many different implant identification methodscurrently in place instead of a common system to allow manufacturers,distributors, and healthcare facilities and professionals to effectivelytrack, identify, and manage implant devices and medical device recalls.The U.S. Food and Drug Administration recently announced a programfocusing on requirements for unique device identifiers for every medicalimplant device to address the need for a more robust implant deviceidentification system, the details of which are incorporated byreference herein: www.fda.gov/udi.

SUMMARY OF THE INVENTION

In accordance with an aspect of the invention, an implant deviceidentifiable after implantation is provided comprising a main portion ofthe implant device and a readable portion of the implant device. Thereadable portion may comprise a radiopaque element and indicia disposedon at least one surface thereof or disposed within the implant. Theindicia may include a plurality of modifications to at least one surfaceof the radiopaque element or a plurality of radiopaque elements disposedwithin the readable portion such that the indicia are discernible by atleast one of x-ray, fluoroscopy, computed tomography, electromagneticradiation, ultrasound, and magnetic resonance imaging.

In accordance with further aspects of the invention, the readableportion may be integral with the main portion. The readable portion mayalso be disposed upon the main portion. The plurality of modificationsmay include an array of holes in the at least one surface of theradiopaque element. The plurality of modifications may include an arrayof notches or variations of density in the at least one surface of theradiopaque element. The array of notches in the at least one surface ofthe radiopaque element may form at least one bar code. The at least onebar code may comprise a Hamming code. The plurality of modifications maybe less than or equal to two centimeters in length.

In accordance with further aspects of the invention, a system foridentifying an implantable device is provided comprising an implantabledevice comprising a main portion and a readable portion. The readableportion may comprise a radiopaque element and indicia disposed on atleast one surface thereof. The indicia may include a plurality ofmodifications to at least one surface of the radiopaque element or aplurality of radiopaque elements disposed within the readable portion.The indicia may further include a database containing a plurality ofrecords associated with a plurality of implantable devices and a userinterface comprising means for displaying information associated withthe indicia based on the plurality of records. The indicia may bediscernible by at least one of x-ray, fluoroscopy, ultra-sound computedtomography, electromagnetic radiation, ultrasound, and magneticresonance imaging.

The plurality of modifications may include an array of holes in the atleast one surface of the radiopaque element. The plurality ofmodifications may include an array of notches in the at least onesurface of the radiopaque element. The array of notches in the at leastone surface of the radiopaque element may form at least one bar code.The at least one bar code may comprise a Hamming code.

In accordance with further aspects of the invention, a method ofidentifying a micromanufactured implant device is provided comprisingdiscerning indicia by at least one of x-ray, fluoroscopy, computedtomography, electromagnetic radiation, ultrasound, and magneticresonance imaging. The indicia may include a plurality of modificationsto at least one surface of a radiopaque element or a plurality ofradiopaque elements disposed within a readable portion. The method ofidentifying a micromanufactured implant device may further compriseaccessing a plurality of records associated with at least one of aplurality of implantable devices and providing information associatedwith the micromanufactured implant based on the indicia and theplurality of records. As used herein, the term “micromanufactured”encompasses all microfabrication techniques such as additivemanufacturing and micromachining, and use of this term is not intendedto limit the size or scale constraints or the type of the manufacturingprocess in any way. The term is used to elucidate the desire for thedetectable portion of the implant device of the present invention to beeither an incorporated portion of an implant or of a size capable ofbeing implanted.

In accordance with further aspects of the invention, the method ofidentifying a micromanufactured implant device may further comprisedisplaying information associated with the micromanufactured implantbased on the indicia and the plurality of records through a userinterface. The readable portion may be disposed upon a main portion ofthe micromanufactured implant device. The plurality of modifications mayinclude an array of holes in the at least one surface of the radiopaqueelement. The plurality of modifications may include an array of notchesin the at least one surface of the radiopaque element. The array ofnotches in the at least one surface of the radiopaque element may format least one bar code. The at least one bar code may comprise a Hammingcode or other similar methods for error detection and correction thatare known in the coding theory art. Additionally, data compression maybe used in the coded indicia of the preferred embodiment.

In accordance with further aspects of the invention, an implant deviceidentifiable after implantation is provided comprising a main portion ofthe implant device and a readable portion of the implant device. Thereadable portion may comprise a plurality of laminae or laminar planes(a finite planar volume). Each of the laminae, hereafter referred to as“laminar planes,” may comprise separately readable indicia such that theindicia may be discernible in three dimensions by at least one of x-ray,fluoroscopy, computed tomography, electromagnetic radiation, ultrasound,and magnetic resonance imaging.

The readable portion may be integral with the main portion. Also, thereadable portion may be disposed upon the main portion. Further, theindicia may include an array of voids on or in a corresponding laminarplane of the readable portion. The indicia may include an array ofembedded markers on or in a corresponding laminar plane of the readableportion. The embedded markers may comprise a modulation of materialcompositions such that a first material composition of at least onefirst embedded marker is different than a second material composition ofat least one second embedded marker. Further, the indicia may include afirst array of embedded markers on or in a first laminar plane of thereadable portion and a second array of embedded markers on or in asecond laminar plane of the readable portion. The first array maycomprise a first embedded marker having a first material compositiondifferent than a second material composition of a second embedded markerdisposed in the second array. The indicia may comprise information inthe form of a code. The code may comprise a Hamming code or othersimilar methods for error detection and correction that are known in thecoding theory art. Additionally, data compression may be used in thecoded indicia of the preferred embodiment.

In accordance with further aspects of the present invention, a method ofmanufacturing an identifiable implant device is provided comprisingproviding a main portion of the implant device, providing a readableportion of the identifiable implant device, printing a first materialonto a first readable portion surface to create a first printed layer,and printing the first material onto the first printed layer to create asecond printed layer. The printing of the first material onto the firstreadable portion surface or the printing of the first material onto thefirst printed layer may comprise printing encoded indicia. The encodedindicia may comprise voids in the first material or measurablevariations in density. The method of manufacturing an identifiableimplant device may further comprise printing a second material onto atleast one of the first readable portion surface and the first printedlayer, such that the encoded indicia comprises the second material.

In accordance with further aspects of the present invention, an implantdevice identifiable after implantation is provided comprising a mainportion of the implant device and a readable portion of the implantdevice. The readable portion comprises an internal structure inside thereadable portion. The internal structure comprises a plurality oflinking structures. Each of the linking structures has a predeterminedsize or orientation. The linking structures are interconnected tosubstantially form the internal structure. The linking structures formpredetermined indicia such that the indicia are discernible by x-ray,fluoroscopy, computed tomography, electromagnetic radiation, ultrasound,and/or magnetic resonance imaging. The readable portion may be integralwith the main portion or disposed upon the main portion. The indicia inthe readable portion of the implant device may comprise a Hamming codeor other similar methods for error detection and correction that areknown in the coding theory art. Additionally, data compression may beused in the coded indicia of the preferred embodiment.

BRIEF DESCRIPTION OF THE FIGURES

While the specification concludes with claims particularly pointing outand distinctly claiming the present invention, it is believed that thepresent invention will be better understood from the followingdescription in conjunction with the accompanying Drawing Figures, inwhich like reference numerals identify like elements, and wherein:

FIG. 1 is a side perspective view of a micromanufactured identifiableimplant device in accordance with aspects of the present invention;

FIG. 2 is a side perspective view of a micromanufactured identifiableimplant device in accordance with further aspects of the presentinvention;

FIG. 3 is a side perspective view of a micromanufactured identifiableimplant device in accordance with further aspects of the presentinvention;

FIG. 4 is a front perspective view of a micromanufactured identifiableimplant device in accordance with further aspects of the presentinvention;

FIG. 5 is a front perspective view of a micromanufactured identifiableimplant device in accordance with further aspects of the presentinvention;

FIG. 6 is a front perspective view of a micromanufactured identifiableimplant device in accordance with further aspects of the presentinvention;

FIG. 7 is an enlarged cross sectional view of a micromanufacturedidentifiable implant device in accordance with further aspects of thepresent invention;

FIG. 7A is an enlarged cross sectional view of a micromanufacturedidentifiable implant device in accordance with further aspects of thepresent invention;

FIG. 8 is a diagram relating to indicia data of a micromanufacturedidentifiable implant device in accordance with further aspects of thepresent invention;

FIG. 8A is a diagram relating to indicia data of a micromanufacturedidentifiable implant device in accordance with further aspects of thepresent invention; and

FIG. 9 is a side perspective view of a micromanufactured identifiableimplant device in accordance with further aspects of the presentinvention.

DETAILED DESCRIPTION

In the following detailed description of the preferred embodiment,reference is made to the accompanying drawings that form a part hereof,and in which is shown by way of illustration, and not by way oflimitation, a specific preferred embodiment in which the invention maybe practiced. It is to be understood that other embodiments may beutilized and that changes may be made without departing from the spiritand scope of the present invention.

Reference is now made to FIG. 1, which shows an implantable rodstructure 10 having a series of notches 12 in one longitudinal side 14of the rod structure 10. The implantable rod structure 10 of thepreferred embodiment of FIG. 1 features a readable portion 16 shown inFIG. 1 to be integral with a main portion 18 of an implant device 20.Alternatively, the readable portion 16 of the implant device 20 may bedisposed upon the main portion 18 of the implant device 20. The readableportion 16 may be coupled to the main portion 18 by such means asfasteners or adhesives or through interference fit. Each of the notches12 is a modification to the surface of the readable portion 16, has apredetermined width 22, and is located at a predetermined axial position24 so as to create indicia 26 representing one-dimensional data. The rodstructure 10 in the preferred embodiment is a radiopaque structure, suchas a tantalum rod. As will be further described below, the rod structure10 may have a variable density such that the rod structure containsindicia in the form of a variable density internal structure or aparticular mesh structure created by additive manufacturing, therebyincreasing the density of data coding. After implantation, the rodstructure 10 and indicia 26 are detectable and readable via a variety ofmethods such as x-ray, fluoroscopy, computed tomography, electromagneticradiation, ultrasound, and magnetic resonance imaging. The indicia 26 isdetected and received by conventional medical imaging devices. Imagingsoftware, preferably high resolution imaging software, then reads thedata from the indicia 26 to decode and store and/or display theinformation from the implant device 20.

In a first embodiment of the present invention, the data represented bythe indicia 26 on the surface of the rod structure 10 references uniqueinformation located in an external database. One example of suchinformation includes data from the indicia representing a uniquenumerical identifier corresponding to a wealth of manufacturer, patient,surgeon, or surgical procedure information located in an externalhealthcare facility database.

In further embodiments of the present information, the size of theindicia may be decreased, and the density of the data thereby increased,such that additional information beyond mere reference data may berecorded onto the surgical implant. Such embodiments are furtherdiscussed below.

In the preferred embodiment of the present invention, error correctionis used to increase the resolution of the imaging technology, therebyallowing an increase in data density. Error correction is discussed inmore detail below.

Referring now to FIG. 9, rod structure 310 includes a plurality ofthreads 312 in a spiral or helical configuration around thecircumference of the rod structure 310. Although the threads 312 shownin FIG. 9 are continuous to form a screw structure, such as a pediclescrew, the inner diameter 314 between adjacent threads 312 is varied toform indicia. As indicated in FIG. 9, the predetermined indicia allowcoded data to appear within the functional structure of the rodstructure 310 before and after implantation. Alternatively, the outerdiameter 316 of threads 312 may be varied in addition to, or instead of,the variation of the inner diameter 314 to retain coded indicia on therod structure 310. Further, the axial spacing 318 between adjacentthreads 312 may be varied in order to store data. Even further, theparticular shape of the spacing between adjacent threads 312, such as asquare, triangular, or circular shape, may also allow data storage inthe rod structure 310. A variation of this embodiment includes amicromanufactured implant device having indicia in or on the head 320 ofthe rod structure 310, such as coded indicia in the head of a surgicalscrew.

Any of the embodiments, including each particular structure, disclosedin the present application may include encoded implant devices havingthe forms of, or being incorporated into, screws, rods, or other medicaldevices such as shoulder implants, hip implants, knee implants, orcardiovascular devices, stents, etc. One such example of a structure andrelated method of the present invention may be one or more structurallyencoded tantalum rod(s) in a PEEK interbody cage assembly.

Referring now to FIG. 2, an implantable rod structure 40 of a preferredembodiment of the present invention features a series of notches 42around the circumference of the rod structure 40. The implantable rodstructure 40 of the preferred embodiment of FIG. 2 features a readableportion 44 shown in FIG. 2 to be integral with a main portion 46 of animplant device 48. Alternatively, the readable portion 44 of the implantdevice 48 may be disposed upon the main portion 46 of the implant device48. The readable portion 44 may be coupled to the main portion 46 bysuch means as fasteners or adhesives or through interference fit. Eachof the notches 42 is a modification to an exterior surface 50 of thereadable portion 44, has a predetermined width 52, and is located at apredetermined axial position 54 so as to create indicia 56 representingone-dimensional data. The rod structure 40 in the preferred embodimentis a radiopaque structure, such as a tantalum rod. After implantation,the rod structure 40 and indicia 56 are detectable and readable via avariety of imaging methods such as x-ray, fluoroscopy, computedtomography, electromagnetic radiation, ultrasound, and magneticresonance imaging. The notches 42 of the preferred embodiment may becreated using known lathe (machining) techniques or through additivemanufacturing processes, as further discussed below. As opposed toindicia located only on a side of a rod structure as shown in FIG. 1,positioning of indicia 56 around the circumference of the rod structure40, as shown in FIG. 2, increases visibility of the indicia 56 andreadability of the data by imaging methods. The indicia 56 is detectedand received by medical imaging devices, which transmits the data toimaging software with sufficient resolution for accurately resolving theindicia. The imaging software reads the indicia 56 to decode and storeand/or display the information from the implant device 48.

Although the indicia 26 and 56 shown in FIGS. 1 and 2 is oriented in adirection perpendicular to the axis of the rod structures 10 and 40, theindicia of the rod structures 10 and 40 may be oriented in a skewed orslanted orientation such that the indicia is not perpendicular to theaxis of the rod structures 10 and 40. As will be recognized by onehaving ordinary skill in the art, any embodiment of the exemplary rodstructures shown in FIGS. 1-3 and 9 may include notches, threads, orsimilar surface modification. Furthermore, each notch, thread, orsimilar structure may vary in depth, cross-section, or geometric shapeacross the series or array for further data storage.

With regard to the rod structures 10 and 40, one exemplary use of therod structures described in the present invention is in spine fusion.The rod structures may be utilized in spinal cages classified by the FDAas Cement Restrictors, Vertebral Body Replacement Devices (VBR), orInterbody Fusion Devices (IBFD). Another variation of the presentinvention is not limited to rod structures used in spinal cages and mayinclude the use of the rod structures in allograft bone and otherimplantable medical devices. This embodiment of the implant device ofthe present invention may include donor information such as tissueidentification number, donor number, or sterility information. As willbe fully understood by the present invention, such encoding can beaccomplished quickly before implantation.

In a preferred embodiment of the present invention, the data representedby the indicia 56 on the surface of the rod structure references uniqueinformation located in an external database. One example of suchinformation includes the data from the indicia 56 representing a uniqueimplant number corresponding to a wealth of manufacturer, patient,surgeon, or surgical procedure information located in an externalhealthcare facility database.

Error correction is used in a preferred embodiment of the presentinvention to increase the resolution of the imaging technology, therebyallowing an increase in data density for a given measurement technology.By encoding, for example, a number into the implant throughmicro-machined holes and/or notches, sufficient permutations of the codecan be recorded. In a preferred embodiment of an implantable deviceaccording to the present invention, a tantalum marker used in polymerspine implants contains, for one example, 400 micron discrete notches.The full code width and the bit count could, in this example, bedictated by machining precision and accuracy, number of variablemachining widths (e.g., 100 microns, 200 microns, and 300 microns),total bar length, and image resolution. To ensure robustness in theencoding scheme, error correction in the form of a Hamming code isimplemented in the preferred embodiment but any error correction methodknown in the coding theory art could be employed. In the preferredembodiment shown in FIGS. 1 and 2, four variable width notches every 250microns allow eight bits of data to be encoded reliably every millimeterand read by a computed tomography scan with sufficient resolution toidentify the notches. This is an example under the preferred embodimenthaving values that are “power of 2 friendly” in order to clarify oneembodiment of the present invention. The specific values of anyparticular embodiment of the present invention depend upon the imagingand manufacturing resolution, which will improve over time, as onehaving ordinary skill in the art may recognize.

Referring now to FIG. 3, an implantable rod structure 70 of a preferredembodiment of the present invention features multiple materials indiscrete layers 72 to create one-dimensional data around thecircumference of the rod structure 70. The implantable rod structure 70of the preferred embodiment of FIG. 3 features a readable portion 74shown in FIG. 3 to be integral with a main portion 76 of an implantdevice 78. Alternatively, the readable portion 74 of the implant device78 may be disposed upon the main portion 76 of the implant device 78.The readable portion 74 may be coupled to the main portion 76 by suchmeans as fasteners or adhesives or through interference fit. Similar tothe notched indicia shown in FIGS. 1 and 2, the variance of materialacross the layers 72 in the embodiment shown in FIG. 3 creates indicia80 representing data that is readable across the axial dimension of therod structure 70. Alternative embodiments may feature multiple materiallayers readable across a different dimension or a structure having adifferent shape constructed using layers of multiple materials.

Referring again to the preferred embodiment of FIG. 3, each of thedistinct material layers 72 has a predetermined width 82 and is locatedat a predetermined axial position 84 so as to create the indicia 80representing one-dimensional data. At least one of the layers 72 in therod structure 70 of FIG. 3 is a radiopaque structure. In the preferredembodiment each of the layers 72 is composed of a particular materialhaving some degree of opacity. Like the rod structures of FIGS. 1 and 2,after implantation, the rod structure 70 and indicia 80 of the implantdevice 78 of FIG. 3 are detectable and readable via a variety of imagingmethods such as x-ray, fluoroscopy, computed tomography, electromagneticradiation, ultrasound, and magnetic resonance imaging. The indicialayers 72 of the preferred embodiment shown in FIG. 3 are structured soas to be visible from any side of the rod structure 70 to increasereadability of the data by imaging methods. The indicia 80 are detectedand received by medical imaging devices, which transmits the data toimaging software, preferably high resolution imaging software. Theimaging software reads the indicia 80 to decode and store and/or displaythe information from the implant device 78.

The information or data encoded onto or into the implant devices of theembodiments disclosed in the present invention may be detected, decoded,read, transferred, stored, displayed, or processed according to suchmethods and devices disclosed in U.S. Pat. No. 8,233,967 or U.S. PatentApplication Publication No. 2013/0053680, both of which are incorporatedherein by reference.

The implantable device 78 of FIG. 3 is manufactured using additivemanufacturing (AM) techniques. Due to their precision andprogrammability, AM processes may be used for any of the embodimentsshown in FIGS. 1-3 to allow a reduction in the size of the indicia and,therefore, increased density of data included onto the surface of theimplantable rod structure. In some cases, machining may be sufficient toprovide the indicia necessary for the implantable rod structure. Withincreased data density, additional information beyond mere referencedata may be recorded onto the surgical implant 78. The data recordedonto the implant device itself may include the manufacturer, patient,surgeon, or surgical procedure information that would otherwise need tobe stored in and accessed through an external database. Additionally, AMallows complex, mass customized, internal structures otherwiseunavailable with conventional manufacturing, including three-dimensionalstructures discussed in further detail below. Moreover, AM eliminatesthe need for tooling and can therefore allow fabrication of implantswith unique identifiers within the structure with no additional masks,molds or user interaction.

ASTM International formed Committee F42 on Additive ManufacturingTechnologies in 2009 with the mission of setting the standards fordesign, process, and materials with regards to AM. The committee defineda taxonomy of seven sub-technologies that together constitute the fullsuite of AM techniques. The seven sub-technologies are described in ASTMF2792-12a, the details of which are incorporated by reference herein.

Material extrusion is an additive manufacturing process where materialis selectively dispensed through an extrusion nozzle. The most commonimplementation of this method involves the extrusion of thermoplasticmaterial through a heated orifice. The materials available for the mostcommon implementation tend to be functional plastics that aresufficiently robust to withstand harsh environments such as chemical,mechanical, or temperature exposure.

Vat photo polymerization features a vat of liquid photo curable polymerthat is selectively cured with an energy source such as a laser beam orother optical energy. The part is typically attached to a platform thatdescends one cure depth after a layer is completed and the process isrepeated. This class of additive manufacturing benefits from featuresizes dictated by either the laser beam width or optical resolution inthe X and Y axis and minimum cure depth in Z.

Powder bed fusion processes include selectively melting or sintering alayer of powder using an energy source such as a laser or electron beam,lowering the layer by a fabrication layer thickness, and adding a newpowder layer by delivery with a rake or roller and material storagemechanism. The process continues with the next layer. Unmelted powder inthe bed acts inherently as support material for subsequently builtlayers.

Material jetting uses ink-jetting technology to selectively deposit thebuild material with a cure prior to the application of subsequentlayers. An exemplary version of this technology may be ink-jettingmultiple photo-curable polymers and follow the inkjet head with a UVlamp for immediate and full volume curing. With multiple materials,fabricated items can be multi-colored or materials can be chosen withvarying stiffness properties. Ink-jetting is also naturally well suitedfor parallelism and thus can be easily scaled to larger and fasterproduction.

Binder jetting includes selectively ink-jetting a binder into a layer ofpowder feedstock. Additional powder material is then dispensed from amaterial storage location by a rake or roller mechanism to create thenext layer. Some binder jetting technologies may require a post-annealfurnace cycle depending on the materials being used (e.g., metals,ceramics). One exemplary system may inkjet color (much like a commercialinkjet color printer) in addition to the binder into a powder, and maytherefore provide structures with colors throughout the structure forconceptual models. Another binder jetting system may utilize a postanneal process to drive out the binder to produce metal or ceramicstructures.

Sheet lamination is another additive manufacturing process in whichindividual sheets of material are bonded together to formthree-dimensional objects. In one exemplary embodiment, sheets of metalare bonded together using ultrasonic energy. The process has been shownto produce metallurgical bonds for aluminum, copper, stainless steel,and titanium. A subsequent subtractive process between layers addsinternal structures and other complex geometries impossible withconventional subtractive manufacturing processes that start from abillet of material.

Directed energy deposition is another additive manufacturing processthat directs both the material deposition and the energy source(typically a laser or electron beam) at the surface being built.Directed energy deposition processes typically use powder or wire-fedmetals and exemplary applications of the process may include repair ofhigh value components used in aircraft engines.

The implant device of the present invention may be manufactured byconventional methods such as a machining operation using any milling,lathe, or drilling operation to include standard machining andfabrication methods known in the art of manufacturing medical implants.

The embodiments of FIGS. 1-3 show an implantable rod structure having alength of one centimeter. Exemplary embodiments of each implant deviceshown in FIGS. 1-3 include each notch or material variation having athickness of 0.1-0.3 millimeters, which results in storage of about30-40 bits of information on the implantable rod structure. Afterutilizing bits for Hamming code error correction, about 25-35 actualdata bits create approximately 30 million to 30 billion indexing optionsinto an external database or for limited information stored on theimplant such as an implant expiration date and lot number.

Referring now to FIG. 4, an implantable plate structure 100 of apreferred embodiment of the present invention features a two-dimensionalarray of modifications 102 to a surface 104 of the plate structure 100.The implantable plate structure 100 of the preferred embodiment of FIG.4 features a readable portion 106 shown in FIG. 4 to be integral with amain portion 108 of an implant device 110. Alternatively, the readableportion 106 of the implant device 110 may be disposed upon the mainportion 108 of the implant device 110. The readable portion 106 may becoupled to the main portion 108 by such means as fasteners or adhesivesor through interference fit. The modifications 102 to the surface 104 ofthe plate structure 100 shown in FIG. 4 are holes 112 that aremicromanufactured through the surface 104 of the plate structure 100.The plate structure 100 may be composed of any material such as a metal,polymer, or ceramic compatible with the imaging modality selected.

The preferred embodiment shown in FIG. 4 features a plate structure 100that is one centimeter squared and one millimeter thick and has aseven-by-seven array of holes 112. The holes 112 are spaced about onemillimeter from each other to provide 49 bits. After subtracting bitsused for error correction, approximately four trillion reliable databaseentry fields with error correction are provided by the seven-by-sevenarray of holes 112. A separate database entry field for every human onEarth requires an implantable device having 33 bits of data—sufficientto uniquely identify over 8 billion cases. An additional eight bits isneeded if each person on Earth were allocated up to 256 implants each. AHamming code is implemented in the preferred embodiment of theimplantable device with an additional eight bits to provide for thedetection and correction of single bit errors.

Referring now to FIG. 5, an implantable plate structure 140 of apreferred embodiment of the present invention features a two-dimensionalarray of embedded markers 142 located at an internal plane 144 of theimplantable plate structure 140. The embedded markers 142 of thepreferred embodiment are internal volumes of a second material ofdifferent density. The implantable plate structure 140 of FIG. 5features a readable portion 146 shown in FIG. 5 to be disposed upon amain portion 148 of an implant device 150. Although not shown in FIG. 5,the readable portion 146 may be coupled to the main portion 148 by suchmeans as fasteners or adhesives or through interference fit.Alternatively, the readable portion 146 of the implant device 150 mayintegral with the main portion 148 of the implant device 150. The secondmaterial having a different density than the plate structure shown inFIG. 5 may be a substance of any material phase including a solid,liquid, or a gas. The embedded markers 142 as an array of internalvolumes of FIG. 5 may also be voids in the material of the readableportion 146 of the implantable plate structure 140. The implantableplate structure 140 may be composed of any material such as a metal,ceramic, or polymer.

Similar to the plate structure of FIG. 4, the preferred embodiment shownin FIG. 5 features a plate structure 140 that is one centimeter squaredand one millimeter thick and has a seven-by-seven array of internalvolumes or voids forming embedded markers 142. The volumes are spacedabout one millimeter from each other to provide 49 bits. Aftersubtracting bits used for error correction, four trillion reliabledatabase entry fields with error correction are provided by theseven-by-seven array of volumes or voids. A separate database entryfield for every human on Earth requires an implantable device having 33bits of data. An additional eight bits is needed if each person on Earthwere allocated up to 256 implants each. A Hamming code is implemented inthe preferred embodiment of the implantable device with an additionaleight bits to provide for the detection and correction of single biterrors.

Referring now to FIG. 6, an implantable structure 170 of a preferredembodiment of the present invention features a three-dimensional array186 of embedded markers 176 located on a series of internal planes 174of the implantable structure 170 that are separated across the z-axis ofthe implantable structure 170. Each of the internal planes 174 shown inFIG. 6 comprise a three-dimensional array of embedded markers 176. Theembedded markers 176 in the preferred embodiment are internal volumes ofa second material of differing density than a first material forming theremainder of the implantable structure 170. The embedded markers 176 mayadditionally be composed of a material differing from both the first andsecond materials forming an identifiable implant device having three ormore materials, similar to the implant device shown in FIG. 3. Thismaterial modulation further increases the density of data recorded inthe implant structure 170.

The implantable structure 170 of the preferred embodiment of FIG. 6features a readable portion 178 shown in FIG. 6 to be disposed on a mainportion 180 of an implant device 182. Although not shown in FIG. 6, thereadable portion 178 may be coupled to the main portion 180 by suchmeans as fasteners or adhesives or through interference fit.Alternatively, the readable portion 178 of the implant device 182 may beintegral with the main portion 180 of the implant device 182. The secondmaterial having a different density than the implantable structure 170shown in FIG. 6 may be a substance of any material phase including asolid, liquid, or a gas. The array of internal volumes of FIG. 6 formingembedded markers 176 may also be voids in the material of the readableportion 178 of the implantable structure 170. The implantable structure170 may be composed of any material such as a metal, ceramic, orpolymer.

As with the embodiment shown in FIG. 5, each plane 174 in thethree-dimensional array 186 of the preferred embodiment shown in FIG. 6features a unique seven-by-seven two-dimensional array 184 of embeddedmarkers 176. The implantable structure 170 of FIG. 6 features the sevenunique two-dimensional arrays 184 along the planes 174 such that theseven-by-seven-by-seven three-dimensional array 186 is formed. Data isextracted from the three-dimensional array 186 shown in FIG. 6 throughvolume imaging used with an extraction algorithm and advanced errorcorrection coding in three dimensions. Due to the large amount of datawithin the internal array 186 of the implantable structure 170 shown inFIG. 6, external databases would not be required to access detailedimplant manufacturing information, patient records, surgery data, orother related medical records. Through image analysis, medical staffwould have immediate access to medical records encoded entirely withinthe implant device 182.

Reference is now made to FIG. 7, which shows an implantable structure200 of a preferred embodiment of the present invention. The implantablestructure 200 of the preferred embodiment is a metal mesh structurefabricated using additive manufacturing (also known in the art as 3Dprinting). The Materials Science & Engineering article titled“Characterization of Ti-6Al-4V Open Cellular Foams Fabricated byAdditive Manufacturing Using Electron Beam Melting” by Murr, et al.discusses such additive manufacturing methods to produce such exemplarystructures as are displayed in the article, and is incorporated hereinby reference. Through an AM manufacturing process, a unique internalstructure is formed while maintaining the structural requirements of theimplant device 200. A readable portion 202 includes an internalstructure 204 inside the readable portion 202. The internal structure204 includes linking structures 206 that interconnect to form theinternal structure 204. Individual linking structures 206 in thepreferred embodiment shown in FIG. 7 each have a predetermined size andorientation in reference to a unique registration structure that wouldbe included in every implant and easily identifiable. As shown in FIG.8, the size and orientation of a particular linking structure 206 of thepreferred embodiment of the present invention is predetermined torepresent binary data. As with the embodiments of the present inventionshown in FIGS. 1-6, the data is read to gather valuable informationrelating to the implant, patient, surgical operation, etc. The datacontained in the readable portion 202 of the implantable structure 200can be accurately read through non-invasive means such as x-ray,fluoroscopy, computed tomography, electromagnetic radiation, ultrasound,and magnetic resonance imaging. FIGS. 7A and 8A show, in detail, thereadable portion 202, internal structure 204, and linking structure 206of the implantable structure 200 according to one embodiment of thepresent invention.

One or more of the embodiments of the present invention are structurallyencoded devices, which refers to the 3D encoding of digital informationin a structure as variations in geometric or physical features—widths,densities, color, feature angles, etc. Bar codes are an example of a 2Dencoding of digital information with modulations of color (dark versuslight) with varying widths of printed bars on a surface. A typicalembodiment of the structurally encoded devices of the present inventionmay contain data that is not readily apparent to a viewer of the devicestructure. Further, encoding of the typical embodiments of the presentinvention is handled by physical means other than those accomplishedthrough circuitry, electromagnetic or other, within the implant deviceitself or through a type of internal storage means such as magneticstorage means or the like. Such structurally encoded devices, asdisclosed herein and described in relation to the typical and/orpreferred embodiments of the present invention allow simplifiedproduction, maintenance, and/or operation costs for identification,storage, and/or retrieval of unique implant data while retaining asubstantial amount of information with reduced probability for error.

The preferred embodiments of the present invention, as shownindividually in FIGS. 1-9, may be manufactured by one or more of the AMprocesses described above. The method of manufacturing an identifiableimplant according to a preferred embodiment of the present inventioncomprises providing a main portion of an identifiable implant device,providing a readable portion of an identifiable implant device, printinga first material onto a first readable portion surface to create a firstprinted layer, and printing the first material onto the first printedlayer to create a second printed layer. At least one of the printing ofthe first material onto the first readable portion surface and theprinting of the first material onto the first printed layer comprisesprinting encoded indicia. Further, the encoded indicia may comprisevolumes of a second material having a different density than the firstmaterial found elsewhere in the readable portion of the identifiableimplant device. As an example, the readable portion of an identifiableimplant may be formed by an AM or 3D printing process such thatmicro-volumes of a metal material having a relatively high density aredeposited within a polymer substrate having a relatively low density.The encoded indicia may also comprise voids in the first material of theidentifiable implant device. Further, any single embodiment of thepresent invention may be manufactured using a combination of traditionalmanufacturing processes and additive manufacturing processes. Forexample, a 3D printed implant device with internal indicia formed by the3D printing process may also have a series of notches micromachined ontoan exterior surface of the 3D printed implant device.

The identifiable implant device of the present invention enables moreaccurate reporting, reviewing, and analyzing of adverse event reports sothat problem devices can be identified and corrected more quickly.Additionally, the identifiable implant device of the present inventionreduces medical error by enabling health care professionals and othersto rapidly and precisely identify a device and obtain importantinformation concerning the characteristics of the device. The presentinvention enhances analysis of devices on the market by providing astandard and clear way to document device use in electronic healthrecords, clinical information systems, claim data sources, andregistries. Through the identifiable implant device of the presentinvention, a more robust post-market surveillance system may also beleveraged to support premarket approval or clearance of new devices andnew uses of currently marketed devices. The present invention furtherprovides a standardized identifier that will allow manufacturers,distributors, and healthcare facilities to more effectively managemedical device recalls. Moreover, the present invention provides afoundation for a global, secure distribution chain, helping to addresscounterfeiting and diversion and prepare for medical emergencies. Theidentifiable implant device of the present invention enables developmentof a medical device identification system that is recognized around theworld.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

I claim:
 1. An implant device identifiable after implantation,comprising: an implant body defining a plurality of planes, wherein eachof said planes comprises separately readable indicia such that saidindicia are discernible by at least one of x-ray, fluoroscopy, computedtomography, electromagnetic radiation, ultrasound, and magneticresonance imaging, wherein said indicia comprise at least two sets ofdata that can be read from at least two different respective directionswith respect to said implant body.
 2. The implant device of claim 1,further comprising a main portion of said implant device and a readableportion of said implant device, wherein said readable portion isintegral with said main portion.
 3. The implant device of claim 1,further comprising a main portion of said implant device and a readableportion of said implant device, wherein said readable portion isdisposed upon said main portion.
 4. The implant device of claim 1,wherein said indicia comprises information in the form of a code.
 5. Theimplant device of claim 4, wherein said wherein said code comprises aHamming code.
 6. An implant device identifiable after implantation,comprising: an implant body defining a plurality of planes, wherein eachof said planes comprises separately readable indicia such that saidindicia are discernible in three dimensions by at least one of x-ray,fluoroscopy, computed tomography, electromagnetic radiation, ultrasound,and magnetic resonance imaging.
 7. The implant device of claim 6,further comprising a main portion of said implant device and a readableportion of said implant device, wherein said readable portion isintegral with said main portion.
 8. The implant device of claim 6,further comprising a main portion of said implant device and a readableportion of said implant device, wherein said readable portion isdisposed upon said main portion.
 9. The implant device of claim 6,wherein said indicia include an array of voids on or in a correspondingplane of said implant device.
 10. The implant device of claim 6, whereinsaid indicia include an array of embedded markers on or in acorresponding plane of said implant device, said embedded markerscomprising a modulation of material composition such that a firstmaterial composition of at least one first embedded marker is differentthan a second material composition of at least one second embeddedmarker.
 11. The implant device of claim 6, wherein said indicia includean array of embedded markers on or in a corresponding plane of saidimplant device, said embedded markers comprising a modulation ofmaterial density such that a first material density of at least onefirst embedded marker is different than a second material density of atleast one second embedded marker.
 12. The implant device of claim 6,wherein said indicia include a first array of embedded markers on or ina first plane of said implant device and a second array of embeddedmarkers on or in a second plane of said implant device, said first arraycomprising a first embedded marker having a first material compositiondifferent than a second material composition of a second embedded markerdisposed in said second array.
 13. The implant device of claim 6,wherein said indicia comprises information in the form of a code. 14.The implant device of claim 13, wherein said code comprises a Hammingcode.
 15. An implant device identifiable after implantation, comprising:an implant body comprising at least two detectable elements as indiciadisposed in a layered orientation along at least one of an axial,radial, lateral, diagonal, and combination thereof in said implantdevice, said indicia include at least two material variations having atleast one different material property such that said indicia arediscernible by at least one of x-ray, fluoroscopy, computed tomography,electromagnetic radiation, ultrasound, and magnetic resonance imaging.16. The implant device of claim 15, further comprising a main portion ofsaid implant device and a readable portion of said implant device,wherein said readable portion is integral with said main portion. 17.The implant device of claim 15, further comprising a main portion ofsaid implant device and a readable portion of said implant device,wherein said readable portion is disposed upon said main portion. 18.The implant device of claim 15, wherein said indicia in said implantdevice form at least one bar code.
 19. The implant device of claim 18,wherein said at least one bar code comprises a Hamming code.
 20. Theimplant device of claim 15, wherein a largest dimension of said implantdevice is less than or equal to two centimeters in length.
 21. Animplant device identifiable after implantation, comprising: an implantbody defining a plurality of linking structures, each of said linkingstructures having at least one of a predetermined size and orientation,said linking structures being interconnected to substantially form animplant device structure, and said linking structures formingpredetermined indicia such that said indicia are discernible by at leastone of x-ray, fluoroscopy, computed tomography, electromagneticradiation, ultrasound, and magnetic resonance imaging.
 22. The implantdevice of claim 21, further comprising a main portion of said implantdevice and a readable portion of said implant device, wherein saidreadable portion is integral with said main portion.
 23. The implantdevice of claim 21, further comprising a main portion of said implantdevice and a readable portion of said implant device, wherein saidreadable portion is disposed upon said main portion.
 24. The implantdevice of claim 21, wherein said indicia in said implant device comprisea Hamming code.
 25. An implant device identifiable after implantation,comprising: an implant body comprising at least one detectable elementand indicia as a plurality of modifications to at least one surface ofsaid detectable element or indicia as a plurality of detectable elementsdisposed within said implant device such that said indicia arediscernible by at least one of x-ray, fluoroscopy, computed tomography,electromagnetic radiation, ultrasound, and magnetic resonance imaging.26. The implant device of claim 25, further comprising a main portion ofsaid implant device and a readable portion of said implant device,wherein said readable portion is integral with said main portion. 27.The implant device of claim 25, further comprising a main portion ofsaid implant device and a readable portion of said implant device,wherein said readable portion is disposed upon said main portion. 28.The implant device of claim 25, wherein said plurality of modificationsincludes an array of holes in said at least one surface of saiddetectable element.
 29. The implant device of claim 25, wherein saidplurality of modifications includes an array of notches in said at leastone surface of said detectable element.
 30. The implant device of claim29, wherein said array of notches in said at least one surface of saiddetectable element forms at least one bar code.